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The Effect of Astaxanthin on Hormonal Parameters and Oxidative Stress Indices in Patients With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03991286
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age It is hypothesized that ∼20 fold increase in reactive oxygen species (ROS) generation in Follicular fluid (FF) and granulosa cells of PCOS women plays an adverse role in affecting the IVF success rate. Astaxanthin (3,3'-dihydroxy-β,β'-carotene-4,4'-dione) is a nonprovitamin A carotenoid classified as a xanthophyll and is found in high amounts in the red pigment of crustacean shells (e.g., crabs, shrimp), salmon, trout, and asteroides. It has been demonstrated that astaxanthin displays a wide variety of biological activities, including anti-oxidative, anticancer, and anti-inflammatory effects.

investigators aim to investigate the effect on Astaxanthin administrating on reducing of ROS in FF and induction of antioxidant response elements in PCOS women.


Condition or disease Intervention/treatment Phase
PCOS Dietary Supplement: Astaxanthin 4 mg Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Astaxanthin on Hormonal Parameters and Oxidative Stress Indices in Serum, and Induction of Signaling Pathways in Granulosa Cells in Patients With Polycystic Ovary Syndrome
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Astaxanthin

Arm Intervention/treatment
Placebo Comparator: Placebo

Drug: Placebo

Ovulatory Agent:

Clomiphene Citrate

Other: placebo
Matching placebo pill

Experimental: experimental

Drug: Astaxanthin 4mg

Drug: Ovulatory Agent Clomiphene Citrate

Dietary Supplement: Astaxanthin 4 mg
experimental
Other Name: Algalife, Icelandic Astaxanthin




Primary Outcome Measures :
  1. Serum glucose milligrams per deciliter (mg/dL) levels [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)

  2. Serum insulin milli-International unit/mililliter (mIU/ml) [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)

  3. Serum Folliclestimulating hormone (FSH) mIU/ml levels [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)

  4. Serum testosterone testosterone [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)

  5. Serum hormone (LH) mIU/ml, [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)


Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: Day1(from the day of oocyte retrieval to fertilization confirmation) ]
    using polarized light microscopy

  2. Number of mature(MII) oocyte [ Time Frame: Day1(from the day of oocyte retrieval to fertilization confirmation) ]
    using polarized light microscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria

Exclusion Criteria:

  • Menopause, pregnant or lactating females
  • individuals with diabetes
  • those with hepatic,renal, thyroid or cardiovascular disorders
  • patients with elevated levels of prolactin
  • those who were taking antioxidant supplements within the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991286


Contacts
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Contact: Farin Amidi, professor +98 912 318 8556 amidifardin@yahoo.com

Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Chair: Fardin Amidi, professor Tehran University of Medical Sciences
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03991286    
Other Study ID Numbers: 9611113003
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tehran University of Medical Sciences:
PCOS
Astaxanthin
ROS
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases